TerminatedPhase 2

To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease

A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography and Event-Related Potentials in Patients With AD

Lead sponsor

AstraZeneca

Assets

AZD1446 / Donepezil

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Effect of single and multiple dosing of AZD1446

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2010-018273-38

Org study IDD1950C00011

NCT IDNCT01125683

Timeline

Milestones

Study first posted2010-05-18estimated

Study start2010-06 (month precision)

Primary completion2011-03actual (month precision)

Study completion2011-03actual (month precision)

Last update posted2011-05-13estimated

Assets

Drug assets

AZD1446 Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of probable Alzheimer´s Disease

•Hachinski Ischaemic score < 4

•MSE score 18 to 24

Exclusion criteria

•History of any clinically significant disease or dementia other than Alzheimer´s Disease

•Current major depressive disorder or other major psychiatric disorders

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.

Time frame:Information on these will be collected from the time of randomization, throughout the study.

concentration, descriptive

Secondary/protocol endpoint

Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.

Time frame:Information on these will be collected from the time of informed consent is signed, throughout the study.

event count, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.

Time frame:collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each.

event count, event

Secondary/protocol endpoint/low confidence

To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable

Time frame:Information on these will be collected from the time of informed consent is signed, throughout the study.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.